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AAMI Updates Steam Sterilization Standard

October 23, 2012

A new amendment to the Advancement of Medical Instrumentation (AAMI)’s popular steam sterilization standard ST79 has an annex to help users understand the different chemical indicator class systems used by manufacturers and the Food and Drug Administration (FDA).

Manufacturers put indicators into one of six classes per the international standard 11140-1. The FDA, on the other hand, has three classes, and uses words instead of numbers to describe them, according to Cynthia Spry, an independent clinical consultant who is co-chair of AAMI’s Steam Sterilization Hospital Practices Working Group, which updated the document.

ST79 explains the six classes recognized by manufacturers so users can select the right indicator for their process. Class 1 indicators, for example, inform the user the item was processed. Class 3 indicators measure a specific variable of the process such as the sterilizer’s temperature.

There can be some confusion, however, when the FDA issues a recall notice for a chemical indicator and uses its classification system. The annex helps to translate the FDA’s system into the one used by manufacturers, so that sterilization personnel will understand what exactly is being recalled.

The annex includes a table that shows, for example, what a Class 1 indicator would be called under the FDA’s system and vice versa, Spry says.

In another update, the working group removed the term “flash sterilization” and replaced it with “immediate-use steam sterilization” throughout the document.

The move reflects a broader effort in the sterilization community to avoid the term “flash” to define the process of cleaning, sterilizing, and transporting items for immediate use. The new term was endorsed by AAMI and six other organizations.

The list price for ST79 is $270 and the AAMI member price is $135. The order code is ST79 or ST79-PDF, and the source code is PB. To order copies, call 1-877-249-8226, or shop the AAMI store.

Source: Association for the Advancement of Medical Instrumentation (AAMI)